Summary - FDA

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K A.O 510(k) Summary of Safety and Effectiveness Or 1i 9.
A. 1 Submitter Information FEB 0 62013
Company Name and Addtress: Contact Name:
Asahi Kasei Medical Company, Ltd. Patsy i.Trisler, JD, RAC
1- 105 Kanda Jinbocho, Chiyoda-ku, Vice President, Regulatory and Clinical
Tokyo 10l1-8 10 1,Japan Qserve America, Qserve Group li.
154 Main Street, Suite 42
Charlestown, NH 03603
Telephone: 301-652-5344
Fax: 509-807-7204
Email: patsy.trisler~qservegroup.com
A.2 Date Prepared: May 9, 2012
A.3 Name of Device
3.1 Trade Name: Asahi REXEED-SXILX Series Dialyzer
3.2 Common Name: High Flux Hemodialysis Membrane Dialyzer or High Flux
Hollow Fiber Dialyzer
3.3 Classification Name. Class. Product Code and Panel
Classification Name and Regulation class Product Code Panel
Number _____ _________I_______
High Permeability Hemodialysis 11 KDl Gastroenterology
Systems, Title 21 Code of Federal and Urology
Regulations § 876.5860 _________________ ________
A.4 Substantial Equivalence Claimed to Predicate Device
APS/REXEED, cleared for commercial distribution via 5 10(k) Premarket
Notifications K001250 dated August 16, 2000; K041726 dated July 23, 2004;
KOSI 1187 dated June 8, 2005; and K0825 15, dated October 3, 2008.
A.5 Device Description
The line of Asahi REXEED-SX/LX Series Dialyzer is a family of high permeability
hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal
failure. REXEED-SX/LX Series Dialyzer is designed for single use. REXEEIJSX/LX Series Dialyzer is constructed of hollow fiber (polysulfone) membranes,
housed within a plastic casing of styrene-butadiene block copolymer and are subjected
to electron beam irradiation prior to shipment.
510(k) - Asahi REXEED-SX/LX Series Dialyzer
May 9, 2012 App - Page 2 of 62
1 )a/b9
This Special 5 10O(k) describes the following modifications:
"Manufacturing Process Change: insertion of an additional step to enhance removal
of manufacturing materials.
" Labeling Change: changes to the Instructions for Use to emphasize importance of
following instructions for use.
"Device Modification: change in specification limit of leakage and related physical
properties of hollow fibers for safer treatment and operation.
A.6 Intended Use and Indications for Use
A. REXEED-SXILX Dialyzers is intended for use for hemodialysis treatment
of patients who have chronic or acute renal failure.
B. REXEED SX/LX Dialyzers must be used in accordance with the
instructions for a physician familiar with hemodialysis and -familiar with
the conditions of the patient.
C. REXEED SX/LX Dialyzers have been tested in vitro under single use
conditions.
A.7 Evaluation of Design Modifications
As the basis for Asahi's device evaluation studies and overall process for managing
medical device risk, the company has performed a risk analysis using procedures
based on ISO 14971(2007) "Medical Devices - Application of Risk Management to
Medical Devices". The risk analysis method used to assess the impact of the
modification was Failure Modes and Effects Analysis (FMEA). Design validation or
where appropriate, design verification, and process validation based on the result of
risk analysis and design input were performed to verify those modifications. All test
results meet the acceptance criteria, and proved that those modifications to be
appropriate.
A.8 Conclusion:
Asahi made modifications to the REXEED-SX/LX Series Dialyzer cleared under
KOO01250, K041726, K051 187, and K082515, resulting in the modified REXEEflSX/LX Series Dialyzer. The information and data provided in this Special 5 10(k)
Premarket Notification establish that the modfied REXEED-SXILX Series Dialyzer is
substantially equivalent in intended use/indications for use, design, principle of
operation, technology, materials, specifications, and performance to the predicate
REXEED-SX/LX Series Dialyzer.
510(k) - Asahi REXEED-SX/LX Series Dislyzer
May 9,2012 App - Page 3 of 62
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
2< Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center - W066-G609
Silver Spring, MD 20993-0002
February 6, 2013
Asahi Kasei Medical Co., Ltd.
% Ms. Patsy J. Trisler, JD, RAC
Vice President, Regulatory & Clinical Affairs
Qserve Group B.V.
154 Main Street, Suite #2
CHARLESTOWN NH 03603
Re: K 121409
Trade/Device Name: Asahi REXEED-SXILX Series Dialyzer
Regulation Number: 21 CFR§ 876.5860
Regulation Name: High permeability hemodialysis system
Regulatory Class: II
Product Code: KDI
Dated: December 20, 2012
Received: December 27, 2012
Dear Ms. Trisler:
We have reviewed your Section 5 10(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability
warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA),
it may be subject to additional controls. Existing major regulations affecting your device can be
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Relzister.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies.
Page 2 -Ms. Patsy J. Trisler, JD, RAG
You must comply with all the Act's requirements, including, but not limited to: registration and
listing (21 CER Part 807); labeling (21 CER Part 801); medical device reporting (reporting of
medical device-related adverse events) (21 CER 803); good manufacturing practice requirements
as set forth in the quality systems (QS) regulation (21 CER Part 820); and if applicable, the
electronic product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 10001050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
go to http://www.fda.gov/AboutFDA/CentersOffices/CDPH/CDRHOffiCes/ucml 1I5809.htm for
the Center for Devices and Radiological Health's (CDRI-'s) Office of Compliance. Also, please
note the regulation entitled, "Misbranding by reference to premarket notification" (2ICFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safey/ReportaProblem/default.htm for the CDRI-'s Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number
(800) 638-2041 or (301) 796-7 100 or at its Internet address
hti://www.fda.gov/Medica]Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin RFisher -S
Benjamin R. Fisher, Ph.D.
Director
Division of Reproductive, Gastro-Renal,
and Urological Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
Statement of Indications for Use
510(k) Number (if known): K(121409
Device Name: Asahi RBXEED-SXILX Series Dialyzer
Indications for Use:
A. REXEED-SX/LX Dialyzers is intended for use for hernodialysis treatment of
patients who have chronic or acute renal failure.
B. REXEED SX/L-X Dialyzers must be used in accordance with the instructions
for a physician familiar with hemnodialysis and familiar with the conditions of
the patient.
C. REXEED SXILX Dialyzers have been tested in vitro under single use
conditions.
Prescriotion Use: X AND/OR Over-the-Counter Use: ___
(21 CFR § 801 Subpart D) (21 CER §07SubpartC)
(PLEASE DO NOT WRITE BELOW THIS LINE -
CONTINUE ON ANOTHER PACE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S
2013.02.06,,16:06:01 -05'00'
(Division Sign-Off)
D~son of Reproductive, Gastro-Renal, and
Urologlcal Devices iQ
510(k) Number P

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